Advanced step therapy delivery for an ambulatory infusion pump and system

ABSTRACT

Embodiments relate to systems, methods and devices for delivering a drug or other therapy to a patient with an ambulatory infusion pump configured to provide a series of tolerance-building steps leading up to a plateau delivery rate. The plateau delivery rate is maintained until the prescribed amount of drug or therapy fluid is delivered to the patient. Embodiments of the invention include providing the patient or other user with a mechanism to decrease, or step down, the therapy delivery rate if a tolerance was not achieved at a lower rate, and providing notifications prior to a step up in a dosage delivery rate.

RELATED APPLICATION

This application is a continuation of application Ser. No. 14/525,579filed Oct. 28, 2014, which in turn is a continuation of application Ser.No. 12/631,076 filed Dec. 4, 2009, now U.S. Pat. No. 8,882,701 issuedNov. 11, 2014, each of which is hereby fully incorporated herein byreference.

TECHNICAL FIELD

The invention relates generally to ambulatory infusion pumps and morespecifically to step therapy delivery by an ambulatory infusion pump.

BACKGROUND

Ambulatory infusion pumps are useful for providing a variety of drugtherapies. Ambulatory pumps can be particularly beneficial for therapieswhich must be delivered over an extended period of time.

One such therapy is intravenous immunoglobulin (IVIG). IVIG is usedprimarily to treat immune deficiencies, inflammatory and autoimmunedisorders, and acute infections. Patients receiving IVIG therapiestypically need to build up a tolerance to the IVIG during delivery,meaning that IVIG is initially administered at a low rate and, as theinfusion time progresses, the rate is gradually increased to a steadystate or “plateau” rate that is maintained until the prescribed amountof IVIG has been delivered to the patient. IVIG is not the only therapythat utilizes this type of delivery profile.

While some conventional infusion pumps can accommodate such a deliveryprofile, setting up and programming the profiles on the pumps iscomplicated and time-consuming. Further, many conventional pumps usespreadsheet-based profiles that cannot be adjusted or customized, eitherprior to infusion to accommodate the needs of a particular patient orduring infusion if a patient is not tolerating the delivered drug andneeds to decrease the rate of infusion on demand.

SUMMARY OF THE INVENTION

Embodiments relate to systems, methods and devices for defining a stepdelivery function for an ambulatory infusion pump and delivering, by thepump, a drug according to the step delivery function.

In one embodiment, an ambulatory infusion pump comprises an infusiontherapy delivery mechanism, a graphical user interface (GUI) configuredto receive a plurality of parameters defining a step delivery function,the plurality of parameters comprising an initial rate, a plateau rate,a step duration, a rate increment and a total infusion volume, and aprocessor coupled to the therapy delivery mechanism and configured tocalculate an infusion duration based on at least one of the plurality ofparameters and to cause the therapy delivery mechanism to operate basedon the step delivery function.

In one embodiment, a method of defining a step delivery function for anambulatory infusion pump comprises receiving an initial rate, a plateaurate, a step duration, a rate increment and a total infusion volume, andautomatically determining an infusion duration based on at least theinitial rate, the plateau rate, the step duration, the rate incrementand the total infusion volume.

In one embodiment, an infusion system comprises an initial rate setting,a plateau rate setting, a step duration setting, a rate incrementsetting, a total infusion volume setting, and an infusion durationsetting that is automatically set according to the initial rate setting,the plateau setting, the step duration setting, the rate incrementsetting and the total infusion volume setting.

The above summary of the invention is not intended to describe eachillustrated embodiment or every implementation of the present invention.The figures and the detailed description that follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1a is a front perspective view of an ambulatory infusion pumpaccording to an embodiment.

FIG. 1b is a rear perspective view of an ambulatory infusion pumpaccording to an embodiment.

FIG. 2 is a block diagram of selected elements of ambulatory infusionpump of FIGS. 1a and 1 b.

FIG. 3 is a graphical representation of the various parameters oftherapy delivery according to an embodiment.

FIG. 4 is a view of a delivery profile graphic provided by a ambulatoryinfusion pump graphical user interface (GUI) according to an embodiment.

FIG. 5 is a view of a menu provided by a GUI according to an embodiment.

FIG. 6 is a view of a menu provided by a GUI according to an embodiment.

FIG. 7 is a view of a menu provided by a GUI according to an embodiment.

FIG. 8 is a view of a delayed start graphic provided by a GUI accordingto an embodiment.

FIG. 9 is a view of a delivery profile graphic provided by a GUIaccording to an embodiment.

FIG. 10 is a view of a delivery profile graphic provided by a GUIaccording to an embodiment.

FIG. 11 is a view of a menu provided by a GUI according to anembodiment.

FIG. 12a is a flowchart of a step therapy delivery system according toan embodiment.

FIG. 12b is a flowchart of a step therapy delivery system according toan embodiment.

FIG. 13 is a graphical representation of therapy delivery of a directed“step down” according to an embodiment.

FIG. 14 is a graphical representation of therapy delivery of a directed“step up” according to an embodiment.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION

Embodiments of the invention relate to a step therapy delivery systemfor an ambulatory infusion system. In one embodiment, the ambulatoryinfusion system can be a CADD-Solis® Ambulatory Infusion System fromSmiths Medical ASD, Inc. The ambulatory infusion system can also be ofthe type disclosed in commonly owned U.S. Patent Application Pub. Nos.2008/0065007, 2008/0065016 and 2008/0132844, assigned to Smiths MedicalASD, Inc., which are incorporated by reference herein in theirentireties. In other embodiments, other infusion pumps can be used.

An exemplary ambulatory infusion pump 100 can provide a step deliverytherapy to a patient and is depicted in FIGS. 1a and 1b , and FIG. 2.Ambulatory infusion pump 100 includes a pump control system 103 with aprocessor and memory programmable with selected protocols, profiles andother settings for controlling operation of a pumping mechanism 105.Ambulatory infusion pump 100 can also include a control module 101 forrelaying commands to the control system 103. Control module 101 caninclude a user interface 102 having a display screen 104 and a controlpad 106. Control module 101 can also include a battery door 108,including a knob 110 for locking and unlocking the door 108, whichcovers a battery compartment in which batteries for powering the pump100 can be contained. Control module 101 can also include a power switch112 for turning pump 100 off and on, a USB port 114, or otherappropriate I/O interface, for connecting pump 100 to a computer havingsoftware designed to interface with pump 100, an AC power jack 116 forconnecting an AC power cord for powering pump 100, and a remote dosecord jack 118 for connecting a remote dose cord that provides analternative way to activate patient-controlled dosing.

Infusion pump 100 can further include a replaceable cassette 120connected to control module 101. In one embodiment, cassette 120includes a reservoir containing the medication that is to be deliveredto the patient. Tubing can extend from the cassette 120 and communicatewith an infusion set or catheter to deliver the medication to thepatient. The control module 101 can be used to control the flow ofmedication from the cassette. One example of such a cassette is theCADD® Medication Cassette Reservoir from Smiths Medical ASD, Inc.,though other cassettes can be used in other embodiments. In anotherembodiment, cassette 120 can include tubing that interfaces with aremote medication reservoir such as an IV bag. Tubing can extend fromthe reservoir to the cassette and then to an infusion set or catheter,and flow of medication through the tubing can be controlled with controlmodule 101. One example of such a set is part of the CADD®Administration Set from Smiths Medical ASD, Inc.

A step delivery can be used with various drug therapies, though in oneembodiment a step function for pump 100 is tailored for intravenousimmunoglobulin (IVIG) therapies. IVIG therapies typically require aperiod of initial dosing. Once complete, an increased dosage (or “stepup”) can be periodically delivered. Step delivery allows the infusion ofa drug at an initial rate with step increases to a plateau rate. Ifpatient tolerance is not successful at any rate, the treatment can bescaled back or stopped on demand. Multiple steps down can be applied,reducing the dosage rate down to any previous rate. In otherembodiments, a step delivery profile can be suitable for nutritional andother therapies.

The step delivery profile of the pump 100 is selectively defined byparameters provided to the pump control system 103. In one embodiment:an initial rate, a plateau rate, a step duration, a rate (step) increaseor increment, and a total infusion volume, as shown by diagram 130depicted in FIG. 3 can be provided. An additional parameter, infusionduration 132, does not have to be provided by a user in an embodiment;rather, infusion duration 132 is automatically calculated based upon oneor more of the other parameters in an embodiment. For example, a minimumprogrammable infusion duration is defined by a combination of theinfusion volume, step duration and various rates of delivery. In anembodiment, pump 100 provides a calculated infusion duration 132 afterthe other parameters are programmed. In an embodiment, pump controlsystem 103 also calculates the total number of steps necessary totransition from the initial rate to the plateau rate based on one ormore programmed parameters. During delivery of a step delivery profile,a user may “step down” a delivery rate. In one embodiment, pump 100automatically adjusts one or more parameters of the programmed stepdelivery profile to accommodate the departure from the initial program.This can include adjusting, i.e., lengthening, the total infusionduration automatically. In an additional embodiment, an optional KVO(“keep vein open”) rate 134 is provided, which allows delivery of aminimal amount of drug to help maintain catheter patency. The KVO rate134 can be considered by the pump 100 in determining a calculatedinfusion duration 132 in one embodiment. Thus, in various embodiments,the step calculation function of the pump control system 103 calculatesa single total infusion duration 132 based on the entered parameters andtherefore does not need minimum and maximum duration parameters.

As depicted in FIG. 4, the display screen 104 of the pump 100 provides agraphical user interface (GUI) 140 during operation. An example deliveryprofile graphic 142 when the pump 100 is started is shown on the displayscreen 104. The information displayed on the GUI 140 may vary but caninclude information of most interest to a user or patient duringdelivery, such as the current rate of delivery 144, the mode ofoperation 148, and any other appropriate status indications. In theembodiment of FIG. 4, the pump 100 is in step mode 148. During infusion,the GUI 140 can present an indicator graphic 150, along with thedelivery profile graphic 142, illustrating how far the patient'streatment has progressed. In the example shown, the therapy delivery isin the second of four stages, at a rate of fifteen mL per hour.

As depicted in FIGS. 5-7, programming screens present a user with aninterface to input the parameters defining the therapy delivery. Theuser, potentially a clinician or home health-care provider, can enterthe dosage parameters provided by a prescribing physician. The user canalso utilize the interface to determine the status of treatment andreduce the dosage rate if necessary. In one embodiment, certainparameters or profiles specific to a patient can be retained or storedby pump 100, or by a related computer system, to facilitate quicker,more convenient, and safer use of pump 100; in particular to avoidprogramming errors or delivery of a profile intended for anotherpatient. In other embodiments, individual or multiple profiles can beprogrammed using a related computer system and software, and thendownloaded to one or more pumps 100 for patient therapy.

FIG. 5 depicts a programmed infusion volume 302 of one hundred mL.Infusion volume 302 is the total volume of drug or therapy fluid to bedelivered according to a prescription. Entering a new infusion volume302 resets the configured infusion profile so that therapy deliverystarts at the beginning of a new infusion duration 132 for the patient.

Initial Rate 304 is the rate at which therapy delivery will begin. Thisalso can be the minimum delivery rate that a user can “step down” to.Rate Increment 306 is the amount of desired amount of medicationdelivery increase for each step.

Plateau Rate 308 is the maximum rate at which the pump 100 is to deliverthe medication. The pump 100 begins at the initial rate, and increasesby the rate increment until the plateau rate 308 is reached, absent astep-down indication from a user. The pump 100 can run at this rateuntil the reservoir volume reaches zero or when the predeterminedinfusion volume 302 is delivered. The pump control system 103 cancalculate the rate of delivery that will occur during the plateauportion of the infusion profile based on the infusion volume andinfusion duration, depending on the desired parameters. The pump 100 canbe pre-configured with a maximum allowable rate. For example, a rateabove 250 mL/hr can require a high volume therapy administration set. Alow volume therapy administration set would not accept parameters thatresulted in a plateau rate 308 above 250 mL/hr.

Step Duration 310 is the length of time programmed for each step duringmedication delivery. This time period corresponds to the duration ofeach step's therapy delivery period. The sum of all step duration 310periods for each step required to reach the plateau rate 308, as well asthe length of the plateau period, is then equal to the total infusionduration 132 to deliver the full infusion volume 302.

Infusion duration 132 is the time required to deliver the total infusionvolume 302. In an embodiment, infusion duration 132 is calculated by thepump 100 based on one or more of the initial values programmed for thepatient-specific parameters: infusion volume 302, initial rate 304, rateincrement 306, plateau rate 308, and step duration 310. The user doesnot need to provide a duration value in one embodiment. Once theparameters are entered, the pump control system 103 calculates infusionduration 132.

Reservoir Vol. 316 is the volume of fluid contained in the reservoir orcassette 120. The administrator can configure a standard reservoirvolume 316 which allows the reservoir volume 316 setting to be quicklyreset to that configured value. As shown in FIG. 7, a clinician canadjust the reservoir volume 316 to another amount, resetting thereservoir volume. In one embodiment, the reservoir volume 316 cannot beset to less than the programmed infusion volume 302. The reservoirvolume 316 value decreases as the pumping mechanism is primed ordelivers fluid.

The KVO Rate, or “keep vein open” rate, 134 is optional. It allowsdelivery of a minimal amount of a drug to help maintain catheterpatency. If a delayed start is programmed, the KVO rate 134 is activeduring the initial delay. It is also active after the infusion profileis complete if the reservoir volume 316 programmed is greater than theinfusion volume 302. If a KVO delivery rate 134 is intended at the endof the infusion profile, the reservoir volume must be larger than theinfusion volume so that automatic KVO delivery may occur. The KVOdelivery rate 134 continues until the reservoir volume 316 reaches zeromL or until the pumping mechanism is stopped.

The user can also program a delayed start time (not depicted) that isthe time that the next infusion delivery will begin. It is displayedonly if a delayed start is programmed. FIG. 8 depicts pump 100 indelayed start mode 320. The graphic 330 indicates that the pump 100 isin the first stage of minimum therapy delivery. The time 340 until thedelivery of the therapy increases to the initial rate 304 is alsodisplayed and periodically updated on display screen 104.

FIGS. 9 and 10 depict two examples of the display screen 104 of the pump100 presenting a running status screen 440 indicating the current rateof delivery 144 and that the pump 100 is in the step mode 442 ofoperation. The running status screen 440 includes an example of a stepdelivery icon 448 that includes a status bar 450. The location of thestatus bar 450 in the middle of the delivery icon 448 indicates that thepump 100 is at an intermediate step in the therapy delivery. The pump100 is delivering a medication at a current rate 144 that is less thanthe plateau rate 308.

FIG. 11 depicts GUI menu commands Step Down 460 and Step Up 462 from theadvanced tasks menu that can be used to change the actual current step,i.e. the infusion duration by reducing or increasing the rate of therapyadministration. The step up and step down procedures are describedbelow. After the selection of the Step Down 460 or Step Up 462 commands,the infusion duration time is automatically recalculated in oneembodiment. The displayed total infusion duration 132 value can changeto reflect the new setting, or it can be configured to display theinitial time value and indicate that a change has been directed thatdeviated from the original configuration.

FIGS. 12a and 12b depict flowcharts 500 and 590 of exemplary embodimentsof a step therapy protocol for an ambulatory infusion system. Initially,a clinician or health care provider inputs the desired parameters 502 asdiscussed above. Typical parameters can include total infusion volume,initial rate, rate increment, plateau rate, and step duration in anembodiment. The pump control system 103 will next calculate the initialinfusion duration delivery time 504. Once the settings are confirmed bythe user, the pump 100 can commence the delivery 506 by engaging thepumping mechanism of the pump 100.

The stepped delivery function of the pump 100 is interruptible, forexample a patient may selectively hold at a current level rather thanstepping up to the next level, or may step back to a previous lowertherapy delivery level if tolerance was not achieved. During delivery,the pump 100 also provides patient convenience features, such as anotification at step up transition. The notification can come in advanceof a transition such that a user can check the patient's vitals orcondition prior to a transition.

The pump 100 can receive user input 510 through the GUI 140 during drugdelivery 506. If there is no user input, the delivery mode 506 continuesuntil the pump control system 103 determines that treatment is complete516. The determination of completed treatment can be based on thedelivery of the entered infusion volume 302. When the treatment iscomplete 520, the pumping mechanism can either be deactivated, orreduced to a KVO delivery rate 134 if configured and if reservoir volume316 has not reached zero mL.

If treatment is not complete 520, the pump control system 103 will checkto see if the step duration 310 time period has elapsed 524. If stepduration 310 for the current therapy delivery period has been completed,the pump 100 will advance to the next higher dosage step 526 andincrease the drug delivery 506 by the amount of the rate increment 306.The rate of drug delivery 506 is limited by the plateau rate 308.Optionally, the pump 100 can provide a notification at or before thedosage increase, or prompt the user for a confirmation to acknowledgethe dosage increase before the higher dosage is delivered. The pump 100can continue with drug delivery as before unless prompted by the user510 or treatment is completed 516. If the step duration 310 has notelapsed 528, the pump 100 will continue with drug delivery 506.

If the user inputs a step down command requesting a lower dosage 530,then the pump 100 will reduce the therapy to the lower dosage 532 by theamount of one dosage rate increment 304. In the embodiment depicted inFIG. 12a , the pump 100 will remain at this lower drug delivery 506stage unless requested by the user to provide a higher dosage 540 oruntil treatment is completed 516. The pump 100 can maintain the lowerdelivery rate by setting an internal hold dosage flag 570 that ischecked 574 prior to advancing to a higher dosage step 526. In theembodiment of FIG. 12b , the reduction in dosage causes a recalculation534 of the infusion duration 132 based on the new reduced deliverydosage by the pump control system 103. The user can enter multiple stepdown commands, reducing the dosage by one or more increments, or haltingtreatment completely. In an alternative embodiment, the pump 100 canprompt the user for permission to increase the dosage after another stepduration 310 time period has elapsed.

If the user inputs a request for a higher dosage 540, the pump 100 canprompt the user to enter a passcode 542. The request for a passcode canbe used to prevent the patient receiving treatment for increasing theirdosage without supervision, or to limit the ability to increase thedosage to certain authorized individuals. Passcodes can also be used bydefault for any programming feature or in other situations related tothe use of the pump 100. If a requested passcode does not match 546 thepump 100 remains at the current drug delivery 506 stage. If thepreconfigured passcode is entered the pump 100 advances to the higherdosage stage 548 by the amount of one dosage rate increment 304. In theembodiment of FIG. 12b , the increase in dosage leads to a recalculation550 of the infusion duration 132 based on the increased delivery dosageby the pump control system 103. In the embodiment of FIG. 12a , the holddosage flag 570 can be cleared 572 if the user requests a higher dosagelevel 540. The user can enter multiple step up commands, increasing thedosage by one or more increments, up to the configured plateau rate. Oneskilled in the art will appreciate that other variations or combinationsof the embodiments described in FIGS. 12a and 12b are possible.

FIG. 13 depicts an example of an initial delivery profile 600 and aresulting delivery profile 602 after a decrease or “step down” in dosagerate. If the user experiences an adverse reaction to an increaseddosage, the user can direct the pump 100 to revert back to the previous,lower, dosage level. As illustrated, the selection of the step downcommand option 460, on the GUI 140 of FIG. 11, decreases the therapydosage from the current dosage 604 to the previous lower dosage 606. Thedecrease in dosage increases the overall therapy delivery time by anadditional period 608. The additional period 608 extends the originaldosage period 610 to the new dosage period 612. In this example, theprevious lower dosage 606 rate is maintained for the entire new dosageperiod 612. No automatic increase in dosage is performed by the pump100, though this can vary in other embodiments.

FIG. 14 depicts an example of an initial delivery profile 700 and aresulting delivery profile 702 after an increase or “step up” in thedosage rate. As illustrated, the step up command 462 on the GUI 140 ofFIG. 11 increases the therapy dosage to the next higher dosage 706. Thisdosage then continues for one entire new step duration 310 regardless ofhow far into the current step duration 310 the pump 100 had progressedwhen the “step up” option was initiated. The increase in dosage rate candecrease the overall therapy delivery time by a shortened period 708.This reduces the overall therapy delivery time required to administerthe full infusion volume 302.

Various embodiments of systems, devices and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the invention. It should be appreciated,moreover, that the various features of the embodiments that have beendescribed may be combined in various ways to produce numerous additionalembodiments. Moreover, while various materials, dimensions, shapes,implantation locations, etc. have been described for use with disclosedembodiments, others besides those disclosed may be utilized withoutexceeding the scope of the invention.

Persons of ordinary skill in the relevant arts will recognize that theinvention may comprise fewer features than illustrated in any individualembodiment described above. The embodiments described herein are notmeant to be an exhaustive presentation of the ways in which the variousfeatures of the invention may be combined. Accordingly, the embodimentsare not mutually exclusive combinations of features; rather, theinvention may comprise a combination of different individual featuresselected from different individual embodiments, as understood by personsof ordinary skill in the art.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims for the present invention, it isexpressly intended that the provisions of Section 112, sixth paragraphof 35 U.S.C. are not to be invoked unless the specific terms “means for”or “step for” are recited in a claim.

The invention claimed is:
 1. An ambulatory infusion pump configured todeliver medicament according to a customized delivery profile thatenables a patient to gradually build up a tolerance to the medicamentduring a therapy session, the ambulatory infusion pump comprising: apump control system configured to control operation of a pumpingmechanism according to one or more tolerance-building delivery ratesdefined by a step delivery profile; and a control module incommunication with the pump control system, the control module includinga user interface presenting a step delivery profile graphic representinga diagram graphical representation of the step delivery profile, and anindicator graphic illustrating progress along the step delivery profileduring the therapy session, wherein a y-axis of the step deliveryprofile represents a delivery rate of the medicament, and an x-axis ofthe step delivery profile graphic represents time, wherein the indicatorgraphic moves along the x-axis of the step delivery profile graphic asthe therapy session progresses, and wherein the ambulatory infusion pumpis configured to automatically lengthen a duration of the step deliveryprofile and of the step delivery profile graphic presented on the userinterface along the x-axis upon a scaling back of at least one of theone or more tolerance-building delivery rates in response to a failureto achieve a desired tolerance during the therapy session, and whereinthe user interface is further configured to provide a notification inadvance of a transition from a first tolerance-building delivery rate toa second tolerance-building delivery rate, the notification isconfigured to prompt the monitoring of a vital sign and/or condition ofthe patient prior to the transition, a status of the monitored vitalsign and/or condition of the patient prompts the control module to issuea hold dosage flag, and the hold dosage flag is cleared upon the requestfor an increase in the tolerance-building delivery rate.
 2. Anambulatory infusion pump configured to graphically illustrate progressalong a programmed step delivery profile during a therapy session, theambulatory infusion pump comprising: a pump control system configured tocontrol operation of a pumping mechanism according to one or moredelivery rates defined by the programmed step delivery profile; and acontrol module in communication with the pump control system, thecontrol module including a user interface presenting an indicatorgraphic along with a step delivery profile graphic configured toillustrate progress along the step delivery profile during the therapysession, wherein the user interface is further configured to provide anotification in advance of a transition from a first tolerance-buildingdelivery rate to a second tolerance-building delivery rate, thenotification configured to prompt the monitoring of a vital sign and/orcondition of the patient prior to the transition, wherein a status ofthe monitored vital sign and/or condition of the patient prompts thecontrol module to issue a hold dosage flag, and wherein the hold dosageflag is cleared upon the request for an increase in thetolerance-building delivery rate.
 3. The ambulatory infusion pump ofclaim 2, wherein the pumping mechanism is configured to dispensemedicament for a treatment of at least one of an immune deficiency,inflammation disorder, autoimmune disorder, and/or acute infection. 4.The ambulatory infusion pump of claim 3, wherein the medicament is anintravenous immunoglobulin (IVIG).
 5. The ambulatory infusion pump ofclaim 2, wherein the control module enables adjustment of the stepdelivery profile during the therapy session in response to a failure ofa patient to achieve a desired tolerance at any given delivery rate. 6.An ambulatory infusion pump configured to deliver medicament accordingto a customized delivery profile that enables a patient to graduallybuild up a tolerance to the medicament during a therapy session, theambulatory infusion pump comprising: a pump control system configured tocontrol operation of a pumping mechanism according to one or moretolerance-building delivery rates defined by a step delivery profile;and a control module in communication with the pump control system, thecontrol module including a user interface presenting an indicatorgraphic along with a step delivery profile graphic configured toillustrate progress along the step delivery profile during the therapysession, wherein the user interface is further configured to provide anotification in advance of a transition from a first tolerance-buildingdelivery rate to a second tolerance-building delivery rate, thenotification configured to prompt the monitoring of a vital sign and/orcondition of the patient prior to the transition, wherein a status ofthe monitored vital sign and/or condition of the patient prompts thecontrol module to issue a hold dosage flag, and wherein the hold dosageflag is cleared upon the request for an increase in thetolerance-building delivery rate.